April 30, 2007, 12:00:00PM. By Nate Hendley

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Washington, DC: Since January 2006, the skin ointment Protopic has been packaged with a boxed warning label intended to alert consumers that the product carries a cancer risk. This tough warning was added at the behest of the U.S. Food and Drug Administration (FDA), in response to several cancer cases among users of the drug.

The only problem is, the FDA approved Protopic (for treatment of severe eczema) in December 2000. This means early users of Protopic were unaware of its cancer-risk.

Astellas, Japanese pharmaceutical giant and Protopic manufacturer, estimates that 2.1 million patients in the United States and 5.4 million worldwide have tried Protopic. It's unclear what impact the cancer-warning label will have on usage patterns.

Eczema
Protopic is designed to treat eczema, a widespread problem. Also known as "atopic dermatitis", eczema "is one of the most common skin disorders seen in infants and children, affecting 10 to 15 percent of the childhood population," reads a January 2006 FDA press release.

Patients with eczema have dry, itchy skin. Scratching infected surfaces turns the skin red and raw and causes a great deal of discomfort. A drug that can provide relief for this condition would obviously be welcome by sufferers, which is where Protopic comes in.

Protopic began life as an oral medication called Prograf, which was used by organ transplant patients. Along the way, it was discovered that the drug also helped fight eczema. Protopic was developed as a separate medication.

The FDA has kept a close eye on Protopic ever since the drug became commercially available.

Cancer Link
"As of December 2004, the FDA had received 19 cases of postmarketing reports linking Protopic with cancer-related adverse events," reads FDA literature. "Three cases occurred in children up to 16 years of age and 16 cases occurred in adults. Two deaths in adults were reported related to complications of the cancers and eight hospitalizations were reported and two in pediatric patients."

Accordingly, the FDA issued a public health advisory on Protopic in March 2005. The advisory informed physicians of the possible cancer risk from use of the drug.

While the advisory was couched in careful language ("it may take human studies of ten years or longer to determine if use of Protopic is linked to cancer," reads the notice), it did offer some hard-fast rules. Protopic should only be taken for short periods of time after other medications have failed, stated the FDA. Kids under two and anyone with a weak immune system shouldn't use Protopic at all.

As the FDA's public health advisory made clear, "the long-term safety of Protopic is unknown."

In the meantime, both the FDA and Astellas urge people who use Protopic to avoid sun lamps, tanning beds, ultraviolet light therapy and anything else that might prime the skin for cancer.

People who used Protopic prior to the January 2006 warning label addition and subsequently developed cancer, might want to seek legal help.

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